Hayden Medical

Basic Information

• Brand Name: Hayden Medical
• Primary DI: 00840319751008
• Version / Model: 405-500
• Catalog Number: 405-500
• Company Name: Hayden Medical, Inc.
• Labeler DUNS: 618214410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-22
• Public Version: 1
• Public Version Date: 2023-03-30
• Public Version Status: New
• Public Device Record Key: 634ca792-e629-4071-8806-9a2499f66846

Device Description

Transumbilical Breast Augmentation Instrument Set, includes 5 complete instruments: 405-501 V-Shaped Breast Dissector w/Handle, 405-502 Hockey Stick Breast Dissector w/Handle, 405-503 Bullet Round Tip Breast Dissector Set w/Handle and 4 Tips, 405-511

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDI	DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11290	Open-surgery dissector	A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840319751008	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]